Methods and systems for handling or delivering materials for natural orifice surgery

ABSTRACT

The embodiments disclosed herein relate to various medical systems, including systems that can be used in conjunction with medical devices used in endoscopic surgery. Certain embodiments include various material handling devices that can transport materials between the inside and the outside of an endoscopic surgery patient.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims priority to Provisional Application No.61/371,361, filed Aug. 6, 2010, which is herein incorporated byreference in its entirety.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

This invention was made with government support under Grant No.2611120123004 awarded by the Department of Defense Telemedicine andAdvanced Technology Research Center (TATRC). Accordingly, the governmentmay have certain rights in the invention.

TECHNICAL FIELD

The present invention relates to various material handling and/ordelivery systems and related components, including material handlingand/or delivery systems for performing surgical procedures through anatural orifice or a single incision. Certain embodiments includevarious material handling and/or systems for performing surgicalprocedures in the peritoneal cavity of a patient.

BACKGROUND

Endoscopic medical procedures have been in use for nearly a century, andare used for a number of procedures such as foreign object removal,ultrasonic imaging, injection therapy, and perhaps most recently forsurgical procedures. Endoluminal endoscopic surgery traditionally usesflexible instruments introduced through canals (working channels) in anendoscope to perform a number of procedures, mainly in the peritonealcavity.

Natural orifice translumenal endoscopic surgery (NOTES) is a surgicalprocedure done endoscopically through an incision in tissue (e.g.,stomach, colon, vagina, or bladder) accessible via a natural orifice(e.g., mouth, anus, urethra, or vagina) and can be done without externalincisions, reducing the risk of infection and speeding recovery. Thenatural orifice access point, while having many patient benefits,presents challenges for introducing instrumentation through arestrictive lumen size, and when using multiple tools, as typical inmany laparoscopic procedures for example, tool triangulation can bedifficult.

An alternative to traditional endoscope based techniques is using invivo robots via a natural orifice approach. These in vivo robots can befully introduced into the peritoneal cavity. Once inserted, these robotshave much more freedom and flexibility, as space constraints and tooltriangulation issues are greatly reduced in the insufflated abdominalcavity.

Fully inserting in vivo robots into the body introduces a limitation asthey are physically isolated from the medical professionals performingthe procedure. Without external incisions, there is also a need foradditional functional features, such as workspace lighting, a method ofirrigating and evacuating fluids produced during procedures, and anyother functionalities commonly associated with traditional endoscopicprocedures.

There is a need for an improved material handling system for use withsurgical procedures.

SUMMARY

One embodiment disclosed herein relates to a system for handling and/ordelivering materials during endoscopic surgery, the system including acompliant overtube, a material capture device, and a drive member.

In one embodiment, a system provided herein is configured to transport amaterial between the outside of an endoscopic surgery patient and theinside of the endoscopic surgery patient, the system comprising acompliant overtube having a primary lumen and a proximal end and adistal end; a material capture device including a retaining mechanismdisposed within the primary lumen; and a drive member configured toshuttle the material capture device between the proximal end and thedistal end. The drive member can be a helical drive member disposedwithin the primary lumen. The capture device can further include a tabthat can be disposed between adjoining coils of the helical drive memberand the slot further can be disposed into a slot defined in the wall ofthe primary lumen. The slot can constrain the orientation of thematerial capture device within the primary lumen.

In another embodiment, the system can have a drive member that is ahydraulic or pneumatic system.

In some embodiments, the retaining mechanism comprises a passivespring-type grasper, which, in some embodiments, can comprise a shapememory alloy. A passive spring-type grasper retaining mechanism can beshaped into a plateau-like profile.

In some embodiments, the system can include a motor that drives thedrive member housed within an electronic housing. Motor controls can bedisposed on or within the electronic housing, or the motor can becontrolled using components remote from the electronic housing.

In some embodiments, the system is configured for use in transgastricendoscopic surgery.

In some embodiments, the system includes a compliant overtube comprisingsilicone.

In one embodiment, a method for transporting a material between theoutside of an endoscopic surgery patient and the inside of theendoscopic surgery patient is provided. The method comprises insertingthrough an incision in the endoscopic surgery patient a distal end of acompliant overtube having: a primary lumen; a material capture devicecomprising a retaining mechanism disposed within the primary lumen; anda drive member configured to shuttle the material capture device betweenthe proximal end and the distal end. The method further comprisesretaining the material in the retaining mechanism of the materialcapture device and actuating the drive member to advance the materialcapture device and the retained material from the inside of the patientto the outside of the patient or from the outside of the patient to theinside of the patient. The drive member can be a helical drive memberdisposed within the primary lumen, or the drive member can be ahydraulic or pneumatic system.

In some embodiments, the distal end of the compliant overtube isinserted through an incision that is in a tissue that is accessiblethrough a natural orifice.

In some embodiments, the retaining mechanism comprises a passivespring-type grasper, which, in some embodiments, can comprise a shapememory alloy.

While multiple embodiments are disclosed, still other embodiments of thepresent invention will become apparent to those skilled in the art fromthe following detailed description, which shows and describesillustrative embodiments of the invention.

Accordingly, the drawings and detailed description are to be regarded asillustrative in nature and not restrictive.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an isometric view of the material handling system, accordingto one embodiment.

FIG. 2 is a cross sectional view of a distal portion of a materialhandling system, according to one embodiment.

FIG. 3 is a side view of a material capture device of a materialhandling system, according to one embodiment.

FIG. 4 is a view of a portion of a material handling system with theexterior shown transparently to reveal inner components, according toone embodiment.

FIG. 5A is a cross sectional view of a material capture deviceorientation mechanism for a material handling system, according to oneembodiment.

FIG. 5B is a cross sectional view of a material capture deviceorientation mechanism for a material handling system, according toanother embodiment.

FIG. 6 is a perspective view of a distal portion of the materialhandling system, according to one embodiment.

FIG. 7 is a top view of a motor assembly, a micro-control unit, and apower source for a material handling system, according to oneembodiment.

It is to be understood that the figures are illustrated for simplicityand clarity and are not necessarily drawn to scale. For example, thedimensions of some of the elements in the figures may be exaggerated,relative to other elements, to improve the understanding of aspects andsample embodiments of the invention.

DETAILED DESCRIPTION

The various systems and devices disclosed herein relate to devices foruse in medical procedures and systems. More specifically, the variousembodiments relate to systems that can be used to handle and/or delivermaterials in endoscopic surgery, such as natural orifice translumenalendoscopic surgery (NOTES). Various embodiments of the disclosed systemsand devices can be used to handle and/or deliver or transport one ormore materials between the outside of an endoscopic surgery patient andthe inside of the endoscopic surgery patient. In some embodiments, theprovided systems improve the ability of a medical professional toperform surgical procedures in the peritoneal cavity of a patient,executed through a natural orifice or other access point in conjunctionwith other surgical equipment.

Certain embodiments disclosed herein relate to devices for use inendoscopic surgery, including certain embodiments for use in naturalorifice translumenal endoscopic surgery (NOTES). FIG. 1 depicts oneembodiment of a material handling and/or delivery system 100 having aproximal end 10 and a distal end 20. In the material handling system 100depicted in FIG. 1, the system includes an electronics housing 30 and amaterial handling component 50.

As best shown in FIGS. 1 and 2, the material handling component 50comprises a compliant overtube 200 having a proximal end 60 and a distalend 70 and including a primary lumen 210 disposed therethrough. In someembodiments, one or more additional lumens 230, 240 are also disposedwithin and along the length of overtube 200, as best shown in FIG. 2.The compliant overtube 200 comprises one or more materials that impartflexibility and frictional properties that are conducive to abrasionresistance, while reducing the amount of trauma caused to a patient bythe overtube 200 during a surgical procedure. In one embodiment, theovertube 200 is capable of bending to the contours of a natural orifice,such as the esophagus, as well as the peritoneal cavity.

Materials suitable for use in the overtube 200 include, for example,silicone, PTFE, or vinyl. The type of material selected for use in theovertube 200 may depend on the specific use. For example, silicone maybe used in an overtube 200 for use in transgastric NOTES in order toprovide sufficient flexibility along the length of the esophagus. Inaddition, in some embodiments, the properties of the material used forthe overtube 200 may be modified using known techniques to provide thedesired flexibility, frictional properties, and/or abrasion resistance.For example, the coefficient of friction of materials (e.g., siliconeand other rubbery materials) can be decreased by the addition of wetand/or dry lubricants, or permanently bonded coatings.

Overtube 200 is shaped and dimensioned as appropriate for the desireduse. For example, an overtube 200 for use in transgastric NOTES can havean outer surface of any shape to accommodate the primary lumen 210 andany other lumens, so long as the overall diameter allows the overtube200 to traverse an esophagus having an average bend radius of about 7.5cm.

As best shown in FIGS. 2-4, in one embodiment, a material capture device220 is slidably housed within the primary lumen 210 of the overtube 200.A retaining mechanism 208 is coupled with the material capture device220 to releasably secure one or more materials (e.g., sutures, excisedtissue, tool tips, waste bags, diagnostic sensors, or the like) to thematerial capture device 220. As best shown in FIG. 3, in one embodiment,the retaining mechanism 208 is a passive spring-type grasper comprising,for example a shape memory alloy (e.g., nickel-titanium,copper-zinc-aluminum-nickel, or copper-aluminum-nickel). In thisembodiment, the retaining mechanism 208 is a thin ribbon ofsuper-elastic shape memory alloy shaped into a plateau-like profile inits resting state (shown as dark heavy lines in FIG. 3). The spring-typegrasper retaining mechanism 208 shown in FIG. 3 deforms (shown in lightlines 208 a) to accommodate the insertion of a material 600. In someembodiments, the retaining mechanism 208 can comprise a plurality ofpassive spring-type graspers and/or an alternative passive spring-typegrasper configuration, such as a multipronged grasper (e.g., 3- or4-pronged grasper; not shown). Alternatively, the retaining mechanism208 can be an actively actuated grasper, such as in a hinged jawconfiguration (not shown). In some embodiments, the retaining mechanism208 is actuated using a linear, rotary, hydraulic, or pneumatic actuator(not shown).

Material capture device 220 and retaining mechanism 208 are configuredsuch that, as the material capture device 220 slides between theproximal and distal ends 60, 70 of the compliant overtube 200, the oneor more materials are transported between the proximal and distal ends60, 70 of compliant overtube 200. The material capture device 220 isdimensioned and shaped as appropriate to accommodate a desired retainingmechanism 208 and to allow access to the retaining mechanism 208 at boththe proximal 60 and distal 70 ends of the compliant overtube. In theembodiment shown in FIG. 3, the material capture device 220 is shaped asa hollow section of tube within which a retaining mechanism 208 can beinserted and affixed.

As best shown in FIG. 4, a rotating helical drive member 206 is disposedwithin the primary lumen 210 of compliant overtube 200. In oneembodiment, as best shown in FIGS. 4 and 5A, the material capture device220 is dimensioned to fit within drive member 206 and is operablyassociated with the drive member 206 via an attached tab 204 a that canbe disposed between adjoining coils of the helical drive member 206.Slot 204 b defined in the wall of primary lumen 210 constrains theorientation of tab 204 a, and thereby the orientation of materialcapture device 220, such that rotation of drive member 206 causestranslation of the material capture device 220 axially along thecompliant overtube 200.

Alternatively, as best shown in FIG. 5B, the overtube 200 comprisesoffset tabs 500 a disposed along the length of the interior of primarylumen 210 and material capture device 220 comprises shuttle tabs 500 bto orient the material capture device 220 with respect to the compliantovertube 200.

In a further alternative, the material capture device 220 can have anyknown structure for allowing the device 220 to be urged along the lengthof the overtube 200.

As best shown in FIGS. 1 and 6, the drive member 206 of FIG. 4 isretained within the compliant overtube 200 by an overtube cap 202 on thedistal end 70 of compliant overtube 200 and with an overtube coupling 42on the proximal end 60. In one embodiment the overtube cap 202 isconfigured to provide an access point to interface with other surgicalequipment (not shown), such as an in vivo robot, while minimizing theoverall diameter of the end of the material delivery system 100 that maybe inserted into a patient, thus reducing procedural trauma onsurrounding tissues. In some embodiments, the overtube cap 202 isconfigured to retain the drive member 206 while allowing medicalprofessionals to access the material capture device 220. In anotherembodiment, the overtube coupling 42 is configured to provide access tothe material capture device 220 and provide a location to couple thecompliant overtube 200 to the rest of the material handling system 100.

As best shown in FIGS. 1 and 7, drive member 206 of FIG. 4 is coupled tomotor 400 via a motor coupling 40. The drive member 206 can bereleasably coupled to the motor coupling 40, such that the materialhandling component 50 is detachable from the electronic housing 30. Themotor coupling 40 can be a two-piece design, with one half rigidlyattached to the motor 400, and the other rigidly attached to the drivemember 206, allowing for detachment of the drive member 206 from themotor 400 such that a medical professional can access the materialcapture device 220. To ensure proper alignment of the compliant overtube200 and drive member 206 to the motor 400, an overtube coupling 42 asshown in FIG. 1 can be attached near the proximal end of the overtube200 and coupled to the base plate 32 via an overtube mount 406 locatedon the base plate 32 (FIG. 7). In one embodiment, the overtube mount 406may utilize permanent magnets, embedded both in the base plate 32 and inthe overtube coupling 42, enabling positive coupling and quick removaland re-attachment of the material handling component 50 to theelectronic housing 30 when a medical professional accesses the materialcapture device 220.

In another embodiment (not shown), the drive member may be a hydraulicor pneumatic system where a secondary lumen 230 or tertiary lumen 240 asshown in FIG. 2 may be used as a hydraulic or pneumatic channel to drivethe material capture device 220. In this embodiment, the motor 400 maybe substituted with a hydraulic or pneumatic apparatus.

Continuing with FIGS. 1 and 7, in some embodiments, the motor 400 ishoused in an electronic housing 30 comprising a baseplate 32 and a topplate 34 that are removably attached to one another. In someembodiments, the motor 400 is attached to the baseplate 32 and/or thetop plate 34. The electronic housing 30 can house additional componentssuch as a micro-control unit 402 and/or a power supply 404 for motor400. The micro-control unit 402 and/or the power supply 404 can beattached to the base plate 32 and/or top plate 34 similarly to the motor400. The top plate 34 and base plate 32 can be made of materialssuitable for protecting electronic components from damage. In someembodiments, the base plate 32 and/or top plate 34 may be omitted fromthe material handling system 100.

In one embodiment, as best shown in FIG. 1, the top plate supportsoperational controls 36. Operational controls 36 can include, forexample, momentary contact pushbuttons for automatic and/or manualcontrol of the motor 400, which would propel the drive member 206.Alternatively, operational controls 36 can be located on a separatecomponent (e.g., a computer) that is in electronic communication withone or more components housed in the electronic housing 30.

In one embodiment, the motor 400 may operate using an open-loop logicfrom a micro-control unit 402. The motor speed and the number of coilsper unit length of the drive member 206 can be adjusted to control therate of speed at which the material capture device 220 traverses thelength of the overtube 200. For example, a rotation rate of 650 rpm witha drive member 206 having 3 coils per inch will allow the materialcapture device 220 to traverse an overtube 200 with a length of about 1meter in 10 seconds. The motor speed and number of coils per unit lengthof the drive member 206 can additionally be adjusted to control thelevel of friction between the material capture device 220 and the drivemember 206 and/or the overtube 200.

The micro-control unit 402 can include a motor position sensor (notshown) that can be used to calculate the position of the materialcapture device 220 within compliant overtube 200 based on the rotationcount of the motor 400 and the coil configuration of the drive member206. In one embodiment, as best shown in FIG. 1, the top plate housesone or more location indicators 38 that can be used to display theposition of the material capture device 220 within compliant overtube200.

The provided material handling system 100 can be used to provide thebridge between other surgical instrumentation, such as in vivo robots,and medical professionals. To facilitate this function, the compliantovertube 200 may contain a secondary lumen 230 and/or a tertiary lumen240, as best shown in FIG. 2. These lumens may provide additionalfunctionality for a medical professional, for example a lighting port, avideo port and/or a port for suction and/or irrigation. In oneembodiment, the secondary lumen 230 allows for insertion of a flexiblefiberscope that has integrated lighting and video capabilities, and thetertiary lumen 240 has the structural integrity to sustain pressuresfrom a suction/irrigation pump. Further lumens may also be provided.

In use, the material handling system 100 may be inserted into a personby a medical professional in a number of ways. In one embodiment, thecompliant overtube 200 and the components located within may be passedthrough a natural orifice without active steering, relying only on thecompliance in the system to guide the device into the peritoneal cavity.In another embodiment, an articulated fiberscope may be inserted into asecondary lumen 230, after which the compliant overtube 200 and thecomponents located within may be passed through a natural orifice, as amedical professional actively steers the device with the articulatedfiberscope. In yet another embodiment, the drive member 206, materialcapture device 200, and overtube coupling 42 may be removed from thecompliant overtube 200, an articulated endoscope may be inserted intothe lumen 210 where the removed components were located, after which thecompliant overtube 200 may be passed through a natural orifice, as amedical professional actively steers the device using the articulatedendoscope. The endoscope would then be removed, and the drive member206, material capture device 220, and overtube coupling 42 may bereinstalled on the compliant overtube 200.

Various modifications and additions can be made to the exemplaryembodiments discussed without departing from the scope of the presentinvention. For example, while the embodiments described above refer toparticular features, the scope of this invention also includesembodiments having different combinations of features and embodimentsthat do not include all of the above described features.

1. A system configured to transport a material between the outside of anendoscopic surgery patient and the inside of the endoscopic surgerypatient, the system comprising: a. a compliant overtube having a primarylumen and a proximal end and a distal end; b. a material capture devicecomprising a retaining mechanism disposed within the primary lumen; andc. a drive member configured to shuttle the material capture devicebetween the proximal end and the distal end.
 2. The system of claim 1,wherein the drive member is a helical drive member disposed within theprimary lumen.
 3. The system of claim 2, wherein the capture devicefurther comprises a tab that can be disposed between adjoining coils ofthe helical drive member and further can be disposed into a slot definedin the wall of the primary lumen.
 4. The system of claim 3, wherein theslot constrains the orientation of the material capture device withinthe primary lumen.
 5. The system of claim 1, wherein the drive member isa hydraulic or pneumatic system.
 6. The system of claim 1, wherein theretaining mechanism comprises a passive spring-type grasper.
 7. Thesystem of claim 6, wherein the retaining mechanism comprises a shapememory alloy.
 8. The system of claim 6, wherein the retaining mechanismis shaped into a plateau-like profile.
 9. The system of claim 1, whereina motor that drives the drive member is housed within an electronichousing.
 10. The system of claim 9, further comprising motor controlsdisposed on or within the electronic housing.
 11. The system of claim 9,wherein the motor is controlled using components remote from theelectronic housing.
 12. The system of claim 1, wherein the system isconfigured for use in transgastric endoscopic surgery.
 13. The system ofclaim 1, wherein the compliant overtube comprises silicone.
 14. A methodfor transporting a material between the outside of an endoscopic surgerypatient and the inside of the endoscopic surgery patient comprising:inserting through an incision in the endoscopic surgery patient a distalend of a compliant overtube having: (a) a primary lumen; (b) a materialcapture device comprising a retaining mechanism disposed within theprimary lumen; and (c) a drive member configured to shuttle the materialcapture device between the proximal end and the distal end; retainingthe material in the retaining mechanism of the material capture device;and actuating the drive member to advance the material capture deviceand the retained material from the inside of the patient to the outsideof the patient or from the outside of the patient to the inside of thepatient.
 15. The method of claim 14, wherein the incision is in a tissuethat is accessible through a natural orifice.
 16. The method of claim14, wherein the drive member is a helical drive member disposed withinthe primary lumen.
 17. The method of claim 14, wherein the drive memberis a hydraulic or pneumatic system.
 18. The method of claim 14, whereinthe retaining mechanism comprises a passive spring-type grasper.
 19. Themethod of claim 18, wherein the retaining mechanism comprises a shapememory alloy.